Job Description

Job Description

Clinical Project Manager

Responsibilities:

• Liase with the Medical Affairs team to manage request for study devices and device data for Investigator Initiated Studies
• Liase cross-functionally with the Manufacturing, R&D and Engineering teams to procure study devices for Investigator Initiated Studies
• Liase with the Cloud team to set up remote monitoring capabilities and export device data to relevant stakeholders for Investigator Initiated Studies.
• Ensure appropriate agreements and contracts are executed.
• Determine the priority of requests to ensure efficient resource management.
• Aid in the preparation of project status presentations to Management regularly.
• Prepare project summary reports, develop and track project plans.
• Manage the maintenance of a shared site that organizes and updates central project documents and manage access to the site for users.
• Ensure timelines are being managed and communicated to key stakeholders.
• Review study protocols and other documentation to determine the appropriate quantity of devices needed per study.
• Estimate the total cost of devices and resources required for each study
• Support other clinical study activities within the department as needed.
• Willing to come into the Acton office as needed.
• Perform other duties as required.

Education and Experience:

• Bachelor’s Degree (preferably in Biomedical Engineering or Life Science field)
• 3-7 years of medical device or drug related clinical experience or an equivalent combination of education and experience.
• At least 2 years project management experience is required
• Biomedical engineering
• Must have analytical skills, be detail oriented and have good interpersonal skills.
• Knowledge of agency guidelines and requirements.

Skills/Competencies:

• Excellent written and effective verbal communication skills.
• Proficient project management skills.
• Ability to prioritize multiple timelines and tasks.
• Ability to communicate at all levels of an organization.
• PC skill, word processing, spreadsheet, database, timeline software.
• Internet search and utilization.
• Flexible and able to work in a fast paced environment.
• Team player.

Physical Requirements

• Estimated travel (domestic and international) is approximately 10% per year.

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